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Clinical Validation of Embryo Cinematography

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marcos Meseguer, Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier:
NCT01549262
First received: February 16, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to determine whether the multivariable model for embryo selection (Meseguer et al. 2012) together with undisturbed controlled conditions obtained by a time-lapse incubator system is effective in improving ongoing pregnancy rate in comparison with standard incubator and an embryo selection process based exclusively in morphology.


Condition Intervention
Embryo Diagnosis and Selection
Device: Observe embryo development with "Unisense FertiliTech A/S" (EC Certificte DGM - 673)
Device: Observe embryo development

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Clinical Validation of Embryo Culture and Selection by Morphokinetic Analysis; a Randomized Controlled Trial by Time-lapse System

Further study details as provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:

Primary Outcome Measures:
  • Ongoing Pregnancy Rate [ Time Frame: confirmed 16-18 weeks after embryo transfer ] [ Designated as safety issue: No ]

Enrollment: 843
Study Start Date: February 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Incubator Device: Observe embryo development
Observe embryo development in the traditional manner
Experimental: ESD Time-lapse Monitoring system Device: Observe embryo development with "Unisense FertiliTech A/S" (EC Certificte DGM - 673)
Observation of exact timing of embryo cleavages together with other morphology dynamics parameters.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female patients undergoing assisted reproduction with ICSI, first or second cycle
  • 20 to 38 yers old
  • BMI (18-25)
  • No endometriosis,
  • > 6 Metaphse II oocytes
  • Basal FSH < 12 UI
  • AMH > 7pmol/L

Exclusion Criteria:

  • Hydrosalpinx
  • Recurrent pregnancy loss
  • Severe male factor
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549262

Locations
Spain
IVI Valencia
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
  More Information

No publications provided

Responsible Party: Marcos Meseguer, Embryologist IVI Valencia, Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier: NCT01549262     History of Changes
Other Study ID Numbers: 1009-C-088-IR
Study First Received: February 16, 2012
Last Updated: August 4, 2014
Health Authority: Spain: Ministry of Health

ClinicalTrials.gov processed this record on November 25, 2014